A phase 1b randomised controlled trial of a glucagon-like peptide-1 and glucagon receptor dual agonist IBI362 (LY3305677) in Chinese patients with type 2 diabetes.

Jiang H, Pang S, Zhang Y, Yu T, Liu M, Deng H, Li L, Feng L, Song B, Han-Zhang H, Ma Q, Qian L, Yang W

Nature communications24 Jun 2022Cited by 42 (Europe PMC)

PMID35750681PMCIDPMC9232612DOI10.1038/s41467-022-31328-xPepBankPUB-35750681

Summary

The success of glucagon-like peptide-1 (GLP-1) receptor agonists to treat type 2 diabetes (T2D) and obesity has sparked considerable efforts to develop next-generation co-agonists that are more effective. We conducted a randomised, placebo-controlled phase 1b study (ClinicalTrials.gov: NCT04466904) to evaluate the safety and efficacy of IBI362 (LY3305677), a GLP-1 and glucagon receptor dual agonist, in Chinese patients with T2D. A total of 43 patients with T2D were enrolled in three cohorts in nine study centres in China and randomised in each cohort to receive once-weekly IBI362 (3.0 mg, 4.5 mg or 6.0 mg), placebo or open-label dulaglutide (1.5 mg) subcutaneously for 12 weeks. Forty-two patients received the study treatment and were included in the analysis, with eight receiving IBI362, four receiving placebo and two receiving dulaglutide in each cohort. The patients, investigators and study site personnel involved in treating and assessing patients in each cohort were masked to IBI362 and placebo allocation. Primary outcomes were safety and tolerability of IBI362. Secondary outcomes included the change in glycated haemoglobin A_1c (HbA_1c), fasting plasma glucose (FPG) and post-mixed-meal tolerance test (post-MTT) glucose levels. IBI362 was well tolerated. Most commonly-reported treatment-emergent adverse events were diarrhoea (29.2% for IBI362, 33.3% for dulaglutide, 0% for placebo), decreased appetite (25.0% for IBI362, 16.7% for dulaglutide, 0% for placebo) and nausea (16.7% for IBI362, 16.7% for dulaglutide and 8.3% for placebo). HbA_1c, FPG and post-MTT glucose levels were reduced from baseline to week 12 in patients receiving IBI362 in all three cohorts. IBI362 showed a favourable safety profile and clinically meaningful reductions in blood glucose in Chinese patients with T2D.

CC BYText from Europe PMC. Highlighted sentences are the source of results.

Results from this study13

13 results from studies that gave the peptide. 13 results from people.

01HumanRandomized controlled trialSafety outcome
In Chinese adults with type 2 diabetes, IBI362 (mazdutide) was well tolerated over 12 weeks.
In plain wordsIn Chinese adults with type 2 diabetes, IBI362 (mazdutide) was well tolerated over 12 weeks.
Peptide
Mazdutide
Outcome
Not applicableTolerability and safety
Study
n = 42
Analysis
Primary
Outcome group
Adverse events · Whole body
Studied dose
3.0 mg, 4.5 mg or 6.0 mg · subcutaneous · 12 weeksAs given in this study (human).
Source sentences
Summary
IBI362 was well tolerated.
3 context sentences(design, population, supporting numbers)
Summary · context
Primary outcomes were safety and tolerability of IBI362.
Summary · context
A total of 43 patients with T2D were enrolled in three cohorts in nine study centres in China and randomised in each cohort to receive once-weekly IBI362 (3.0 mg, 4.5 mg or 6.0 mg), placebo or open-label dulaglutide (1.5 mg) subcutaneously for 12 weeks.
Summary · context
Forty-two patients received the study treatment and were included in the analysis, with eight receiving IBI362, four receiving placebo and two receiving dulaglutide in each cohort.
Show in the study text Report a problemFND-3575068101
02HumanRandomized controlled trialEfficacy outcome
In Chinese adults with type 2 diabetes, HbA1c fell from baseline to week 12 with IBI362 in all three cohorts.
In plain wordsIn Chinese adults with type 2 diabetes, HbA1c fell from baseline after 12 weeks of IBI362 in all three dose cohorts.
Peptide
Mazdutide
Outcome
DecreaseHbA1c change at week 12
Study
n: not reported in source
Analysis
Secondary
Outcome group
Glycemic control · Metabolic and weight
Studied dose
3.0 mg, 4.5 mg or 6.0 mg · subcutaneous · 12 weeksAs given in this study (human).
Source sentences
Summary
HbA_1c, FPG and post-MTT glucose levels were reduced from baseline to week 12 in patients receiving IBI362 in all three cohorts.
3 context sentences(design, population, supporting numbers)
Summary · context
Secondary outcomes included the change in glycated haemoglobin A_1c (HbA_1c), fasting plasma glucose (FPG) and post-mixed-meal tolerance test (post-MTT) glucose levels.
Summary · context
A total of 43 patients with T2D were enrolled in three cohorts in nine study centres in China and randomised in each cohort to receive once-weekly IBI362 (3.0 mg, 4.5 mg or 6.0 mg), placebo or open-label dulaglutide (1.5 mg) subcutaneously for 12 weeks.
Summary · context
Forty-two patients received the study treatment and were included in the analysis, with eight receiving IBI362, four receiving placebo and two receiving dulaglutide in each cohort.
Show in the study text Report a problemFND-3575068108
03HumanRandomized controlled trialEfficacy outcome
In Chinese adults with type 2 diabetes, fasting plasma glucose fell from baseline to week 12 with IBI362 in all three cohorts.
In plain wordsIn Chinese adults with type 2 diabetes, fasting blood glucose fell from baseline after 12 weeks of IBI362 in all three dose cohorts.
Peptide
Mazdutide
Outcome
DecreaseFasting plasma glucose change at week 12
Study
n: not reported in source
Analysis
Secondary
Outcome group
Glycemic control · Metabolic and weight
Studied dose
3.0 mg, 4.5 mg or 6.0 mg · subcutaneous · 12 weeksAs given in this study (human).
Source sentences
Summary
HbA_1c, FPG and post-MTT glucose levels were reduced from baseline to week 12 in patients receiving IBI362 in all three cohorts.
3 context sentences(design, population, supporting numbers)
Summary · context
Secondary outcomes included the change in glycated haemoglobin A_1c (HbA_1c), fasting plasma glucose (FPG) and post-mixed-meal tolerance test (post-MTT) glucose levels.
Summary · context
A total of 43 patients with T2D were enrolled in three cohorts in nine study centres in China and randomised in each cohort to receive once-weekly IBI362 (3.0 mg, 4.5 mg or 6.0 mg), placebo or open-label dulaglutide (1.5 mg) subcutaneously for 12 weeks.
Summary · context
Forty-two patients received the study treatment and were included in the analysis, with eight receiving IBI362, four receiving placebo and two receiving dulaglutide in each cohort.
Show in the study text Report a problemFND-3575068109
04HumanRandomized controlled trialEfficacy outcome
In Chinese adults with type 2 diabetes, post-mixed-meal tolerance test glucose fell from baseline to week 12 with IBI362 in all three cohorts.
In plain wordsIn Chinese adults with type 2 diabetes, blood glucose after a test meal fell from baseline after 12 weeks of IBI362.
Peptide
Mazdutide
Outcome
DecreasePost-meal tolerance test glucose change at week 12
Study
n: not reported in source
Analysis
Secondary
Outcome group
Glycemic control · Metabolic and weight
Studied dose
3.0 mg, 4.5 mg or 6.0 mg · subcutaneous · 12 weeksAs given in this study (human).
Source sentences
Summary
HbA_1c, FPG and post-MTT glucose levels were reduced from baseline to week 12 in patients receiving IBI362 in all three cohorts.
3 context sentences(design, population, supporting numbers)
Summary · context
Secondary outcomes included the change in glycated haemoglobin A_1c (HbA_1c), fasting plasma glucose (FPG) and post-mixed-meal tolerance test (post-MTT) glucose levels.
Summary · context
A total of 43 patients with T2D were enrolled in three cohorts in nine study centres in China and randomised in each cohort to receive once-weekly IBI362 (3.0 mg, 4.5 mg or 6.0 mg), placebo or open-label dulaglutide (1.5 mg) subcutaneously for 12 weeks.
Summary · context
Forty-two patients received the study treatment and were included in the analysis, with eight receiving IBI362, four receiving placebo and two receiving dulaglutide in each cohort.
Show in the study text Report a problemFND-3575068110
05HumanRandomized controlled trialSafety outcome
In Chinese patients with type 2 diabetes, diarrhoea occurred in 33.3% of dulaglutide recipients.
In plain wordsIn Chinese patients with diabetes, 33.3% of dulaglutide recipients reported diarrhoea.
Peptide
Dulaglutide (Trulicity)
Outcome
Not applicableDiarrhoea
Study
n = 6
Outcome group
Gastrointestinal adverse events · Gastrointestinal
Studied dose
1.5 mg once weekly · subcutaneous · 12 weeksAs given in this study (human).
Measurements
Diarrhoea
33.3%
dulaglutide
Source sentences
Summary
Most commonly-reported treatment-emergent adverse events were diarrhoea (29.2% for IBI362, 33.3% for dulaglutide, 0% for placebo)
2 context sentences(design, population, supporting numbers)
Summary · context
A total of 43 patients with T2D were enrolled in three cohorts in nine study centres in China and randomised in each cohort to receive once-weekly IBI362 (3.0 mg, 4.5 mg or 6.0 mg), placebo or open-label dulaglutide (1.5 mg) subcutaneously for 12 weeks.
Summary · context
Forty-two patients received the study treatment and were included in the analysis, with eight receiving IBI362, four receiving placebo and two receiving dulaglutide in each cohort.
Show in the study text Report a problemFND-3575068111
06HumanRandomized controlled trialSafety outcome
In Chinese patients with type 2 diabetes, decreased appetite occurred in 16.7% of dulaglutide recipients.
In plain wordsIn Chinese patients with diabetes, 16.7% of dulaglutide recipients reported decreased appetite.
Peptide
Dulaglutide (Trulicity)
Outcome
Not applicableDecreased appetite
Study
n = 6
Outcome group
Appetite and food intake · Metabolic and weight
Studied dose
1.5 mg once weekly · subcutaneous · 12 weeksAs given in this study (human).
Measurements
Decreased appetite
16.7%
dulaglutide
Source sentences
Summary
decreased appetite (25.0% for IBI362, 16.7% for dulaglutide, 0% for placebo)
2 context sentences(design, population, supporting numbers)
Summary · context
A total of 43 patients with T2D were enrolled in three cohorts in nine study centres in China and randomised in each cohort to receive once-weekly IBI362 (3.0 mg, 4.5 mg or 6.0 mg), placebo or open-label dulaglutide (1.5 mg) subcutaneously for 12 weeks.
Summary · context
Forty-two patients received the study treatment and were included in the analysis, with eight receiving IBI362, four receiving placebo and two receiving dulaglutide in each cohort.
Show in the study text Report a problemFND-3575068112
07HumanRandomized controlled trialSafety outcome
In Chinese patients with type 2 diabetes, nausea occurred in 16.7% of dulaglutide recipients.
In plain wordsIn Chinese patients with diabetes, 16.7% of dulaglutide recipients reported nausea.
Peptide
Dulaglutide (Trulicity)
Outcome
Not applicableNausea
Study
n = 6
Outcome group
Gastrointestinal adverse events · Gastrointestinal
Studied dose
1.5 mg once weekly · subcutaneous · 12 weeksAs given in this study (human).
Measurements
Nausea
16.7%
dulaglutide
Source sentences
Summary
nausea (16.7% for IBI362, 16.7% for dulaglutide and 8.3% for placebo).
2 context sentences(design, population, supporting numbers)
Summary · context
A total of 43 patients with T2D were enrolled in three cohorts in nine study centres in China and randomised in each cohort to receive once-weekly IBI362 (3.0 mg, 4.5 mg or 6.0 mg), placebo or open-label dulaglutide (1.5 mg) subcutaneously for 12 weeks.
Summary · context
Forty-two patients received the study treatment and were included in the analysis, with eight receiving IBI362, four receiving placebo and two receiving dulaglutide in each cohort.
Show in the study text Report a problemFND-3575068113
08HumanRandomized controlled trialSafety outcome
In Chinese adults with type 2 diabetes, treatment-emergent diarrhoea occurred in 29.2% with IBI362 and 0% with placebo.
In plain wordsIn Chinese adults with type 2 diabetes, diarrhoea occurred in 29.2% on IBI362 and none on placebo.
Peptide
Mazdutide
Outcome
Not applicableDiarrhoea
Study
n: not reported in source
Comparator
Placebo
Outcome group
Gastrointestinal adverse events · Gastrointestinal
Studied dose
3.0 mg, 4.5 mg or 6.0 mg · subcutaneous · 12 weeksAs given in this study (human).
Measurements
Incidence
29.2%
IBI362
Incidence
0%
placebo
Source sentences
Summary
diarrhoea (29.2% for IBI362, 33.3% for dulaglutide, 0% for placebo)
2 context sentences(design, population, supporting numbers)
Summary · context
A total of 43 patients with T2D were enrolled in three cohorts in nine study centres in China and randomised in each cohort to receive once-weekly IBI362 (3.0 mg, 4.5 mg or 6.0 mg), placebo or open-label dulaglutide (1.5 mg) subcutaneously for 12 weeks.
Summary · context
Forty-two patients received the study treatment and were included in the analysis, with eight receiving IBI362, four receiving placebo and two receiving dulaglutide in each cohort.
Show in the study text Report a problemFND-3575068102
09HumanRandomized controlled trialSafety outcome
In Chinese adults with type 2 diabetes, treatment-emergent diarrhoea occurred in 29.2% with IBI362 and 33.3% with dulaglutide.
In plain wordsIn Chinese adults with type 2 diabetes, diarrhoea occurred in 29.2% on IBI362 and 33.3% on dulaglutide.
Peptide
Mazdutide
Outcome
Not applicableDiarrhoea
Study
n: not reported in source
Comparator
Dulaglutide 1.5 mg (open label)
Outcome group
Gastrointestinal adverse events · Gastrointestinal
Studied dose
3.0 mg, 4.5 mg or 6.0 mg · subcutaneous · 12 weeksAs given in this study (human).
Measurements
Incidence
29.2%
IBI362
Incidence
33.3%
dulaglutide
Source sentences
Summary
diarrhoea (29.2% for IBI362, 33.3% for dulaglutide, 0% for placebo)
2 context sentences(design, population, supporting numbers)
Summary · context
A total of 43 patients with T2D were enrolled in three cohorts in nine study centres in China and randomised in each cohort to receive once-weekly IBI362 (3.0 mg, 4.5 mg or 6.0 mg), placebo or open-label dulaglutide (1.5 mg) subcutaneously for 12 weeks.
Summary · context
Forty-two patients received the study treatment and were included in the analysis, with eight receiving IBI362, four receiving placebo and two receiving dulaglutide in each cohort.
Show in the study text Report a problemFND-3575068103
10HumanRandomized controlled trialSafety outcome
In Chinese adults with type 2 diabetes, treatment-emergent decreased appetite occurred in 25.0% with IBI362 and 0% with placebo.
In plain wordsIn Chinese adults with type 2 diabetes, decreased appetite occurred in 25.0% on IBI362 and none on placebo.
Peptide
Mazdutide
Outcome
Not applicableDecreased appetite
Study
n: not reported in source
Comparator
Placebo
Outcome group
Adverse events · Whole body
Studied dose
3.0 mg, 4.5 mg or 6.0 mg · subcutaneous · 12 weeksAs given in this study (human).
Measurements
Incidence
25%
IBI362
Incidence
0%
placebo
Source sentences
Summary
decreased appetite (25.0% for IBI362, 16.7% for dulaglutide, 0% for placebo)
2 context sentences(design, population, supporting numbers)
Summary · context
A total of 43 patients with T2D were enrolled in three cohorts in nine study centres in China and randomised in each cohort to receive once-weekly IBI362 (3.0 mg, 4.5 mg or 6.0 mg), placebo or open-label dulaglutide (1.5 mg) subcutaneously for 12 weeks.
Summary · context
Forty-two patients received the study treatment and were included in the analysis, with eight receiving IBI362, four receiving placebo and two receiving dulaglutide in each cohort.
Show in the study text Report a problemFND-3575068104
11HumanRandomized controlled trialSafety outcome
In Chinese adults with type 2 diabetes, treatment-emergent decreased appetite occurred in 25.0% with IBI362 and 16.7% with dulaglutide.
In plain wordsIn Chinese adults with type 2 diabetes, decreased appetite occurred in 25.0% on IBI362 and 16.7% on dulaglutide.
Peptide
Mazdutide
Outcome
Not applicableDecreased appetite
Study
n: not reported in source
Comparator
Dulaglutide 1.5 mg (open label)
Outcome group
Adverse events · Whole body
Studied dose
3.0 mg, 4.5 mg or 6.0 mg · subcutaneous · 12 weeksAs given in this study (human).
Measurements
Incidence
25%
IBI362
Incidence
16.7%
dulaglutide
Source sentences
Summary
decreased appetite (25.0% for IBI362, 16.7% for dulaglutide, 0% for placebo)
2 context sentences(design, population, supporting numbers)
Summary · context
A total of 43 patients with T2D were enrolled in three cohorts in nine study centres in China and randomised in each cohort to receive once-weekly IBI362 (3.0 mg, 4.5 mg or 6.0 mg), placebo or open-label dulaglutide (1.5 mg) subcutaneously for 12 weeks.
Summary · context
Forty-two patients received the study treatment and were included in the analysis, with eight receiving IBI362, four receiving placebo and two receiving dulaglutide in each cohort.
Show in the study text Report a problemFND-3575068105
12HumanRandomized controlled trialSafety outcome
In Chinese adults with type 2 diabetes, treatment-emergent nausea occurred in 16.7% with IBI362 and 8.3% with placebo.
In plain wordsIn Chinese adults with type 2 diabetes, nausea occurred in 16.7% on IBI362 and 8.3% on placebo.
Peptide
Mazdutide
Outcome
Not applicableNausea
Study
n: not reported in source
Comparator
Placebo
Outcome group
Gastrointestinal adverse events · Gastrointestinal
Studied dose
3.0 mg, 4.5 mg or 6.0 mg · subcutaneous · 12 weeksAs given in this study (human).
Measurements
Incidence
16.7%
IBI362
Incidence
8.3%
placebo
Source sentences
Summary
nausea (16.7% for IBI362, 16.7% for dulaglutide and 8.3% for placebo).
2 context sentences(design, population, supporting numbers)
Summary · context
A total of 43 patients with T2D were enrolled in three cohorts in nine study centres in China and randomised in each cohort to receive once-weekly IBI362 (3.0 mg, 4.5 mg or 6.0 mg), placebo or open-label dulaglutide (1.5 mg) subcutaneously for 12 weeks.
Summary · context
Forty-two patients received the study treatment and were included in the analysis, with eight receiving IBI362, four receiving placebo and two receiving dulaglutide in each cohort.
Show in the study text Report a problemFND-3575068106
13HumanRandomized controlled trialSafety outcome
In Chinese adults with type 2 diabetes, treatment-emergent nausea occurred in 16.7% with IBI362 and 16.7% with dulaglutide.
In plain wordsIn Chinese adults with type 2 diabetes, nausea occurred in 16.7% on IBI362 and 16.7% on dulaglutide.
Peptide
Mazdutide
Outcome
Not applicableNausea
Study
n: not reported in source
Comparator
Dulaglutide 1.5 mg (open label)
Outcome group
Gastrointestinal adverse events · Gastrointestinal
Studied dose
3.0 mg, 4.5 mg or 6.0 mg · subcutaneous · 12 weeksAs given in this study (human).
Measurements
Incidence
16.7%
IBI362
Incidence
16.7%
dulaglutide
Source sentences
Summary
nausea (16.7% for IBI362, 16.7% for dulaglutide and 8.3% for placebo).
2 context sentences(design, population, supporting numbers)
Summary · context
A total of 43 patients with T2D were enrolled in three cohorts in nine study centres in China and randomised in each cohort to receive once-weekly IBI362 (3.0 mg, 4.5 mg or 6.0 mg), placebo or open-label dulaglutide (1.5 mg) subcutaneously for 12 weeks.
Summary · context
Forty-two patients received the study treatment and were included in the analysis, with eight receiving IBI362, four receiving placebo and two receiving dulaglutide in each cohort.
Show in the study text Report a problemFND-3575068107

AI wrote and checked these results. AI can make mistakes, so check important results against the source.

Registered trials1

Trials this study reports on, or that list this study as a reference. Registry data from ClinicalTrials.gov.

1 trial · 1 completed · source ClinicalTrials.gov (opens in a new tab)

CompletedPhase 1/2NCT04466904

Multiple-dose Tolerability and Pharmacokinetic of IBI362 in Chinese Patients With T2DM

Innovent Biologics (Suzhou) Co. Ltd.n = 4212 Sept 2020 to 28 May 2021

Type 2 Diabetes

Trial page ClinicalTrials.govUpdated 23 Jul 2021

Version history

PepBank keeps every version of the data on this study. Status changes from Retraction Watch, Europe PMC and Crossref are listed with their source.

Versions 4 to 8Current
28 Oct 2026, 02:03 UTC
The same notice was added 5 times, first on 22 Oct 2026, 02:26 UTC. The status did not change between them.
Study results updated
Version 3
21 Oct 2026, 18:59 UTC
Study data updated · source update from Europe PMC
Version 2
9 Oct 2026, 18:17 UTC
Study results updated
Version 1
9 Oct 2026, 02:47 UTC
First added · source update from Europe PMC